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Innovaderm Research Inc.
Innovaderm Research Inc.
201 – 500 Angajați
Asistență medicalăConsultanțăProduse farmaceutice
Innovaderm Research Inc. este o organizație de cercetare contractuală (CRO) axată pe dermatologie, care sprijină dezvoltarea clinică din faza I până în faza IV. Din 2000, compania colaborează cu organizații farmaceutice și din domeniul sănătății din America de Nord și Europa, oferind servicii de proiectare a studiilor, consultanță de reglementare, management de proiect, recrutarea pacienților și gestionarea datelor pentru cercetarea dermatologică.
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Senior Clinical Scientist – Canada Remote

Senior Clinical Scientist supporting clinical and regulatory writing for Indero, a global dermatology and rheumatology CRO. The role covers study design, data interpretation, regulatory submissions, and scientific team support.

CACanadaRemoteNormă întreagăSeniorLimbă Obligatorie: englezăCercetare clinică

Descriere

  • Develop and contribute to clinical and regulatory materials, including protocols, statistical analysis plans, clinical study reports, narratives, abstracts, posters, and manuscripts
  • Support study design activities and review informed consent forms
  • Evaluate statistical analysis plans and associated tables, figures, and listings
  • Analyze, interpret, and review clinical study data
  • Conduct searches of relevant online literature
  • Create and review training resources for scientific teams and the wider organization
  • Coordinate medical writing deliverables, stakeholder communications, project issues, and timelines
  • Provide scientific, therapeutic-area, and medical writing expertise throughout study conduct
  • Mentor and train new and junior team members
  • Conduct quality-control reviews of documents prepared by colleagues
  • Help deliver scientific affairs commitments on schedule, within budget, and in accordance with SOPs and regulations
  • Support organizational enhancements and the introduction of new processes and procedures
  • Participate in quality assurance or client audits as a scientific subject-matter expert
  • Assist business development through proposal synopses, bid-defense materials, sponsor meetings, and responses to sponsor questions
  • Assess scientific affairs assumptions and budgets during RFP activities
  • Provide scientific and medical writing support for pre-IND and IND submissions
  • Offer scientific leadership and, where appropriate, lead cross-functional projects
  • Complete other assigned duties for which qualified and trained

Cerințe

  • Master’s degree in a related discipline or an equivalent combination of relevant education and professional experience
  • At least six years of experience in clinical research
  • At least three years writing clinical or regulatory documents and analyzing and reporting study data in a CRO or pharmaceutical environment
  • Thorough understanding of the drug development lifecycle and relevant regulatory requirements
  • Strong written and verbal English communication skills
  • Advanced English-language writing ability
  • Advanced proficiency in Word, Excel, and PowerPoint, including formatting complex, lengthy documents
  • Ability to manage diverse concurrent assignments and prioritize workload effectively
  • Exceptional attention to detail
  • Client-oriented approach
  • Strong interpersonal and collaborative skills
  • Adaptable, versatile, and able to learn quickly
  • Demonstrated leadership and ability to influence others constructively
  • Working knowledge of Good Clinical Practice and applicable Health Canada and FDA regulations and guidance
  • Legally authorized to work in Canada

Beneficii

  • Permanent full-time employment
  • Flexible working schedule
  • Vacation entitlement
  • Home-based work arrangement
  • Continuing learning and development opportunities
  • Medical, dental, and vision coverage
  • Retirement plan
  • Personal days
  • Virtual medical clinic
  • Public transit discounts
  • Social activities
  • Opportunities for career advancement

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